The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study

ID: NCT00599222
Status: Completed
Phase: Phase 3
Start Date: February 01, 2008
First Submitted: January 10, 2008
Last Updated: November 21, 2011
Results: N/A
Organization: St. Erik Eye Hospital
Sponsors & Collaborators: Anders Kvanta
Location: Sweden
Conditions: Neovascular Age-related Macular Degeneration
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Study Description

Brief Summary

Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss in the Western world. Intravitreal ranibizumab has recently become the treatment of choice for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. The investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.

Detailed Description

Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. For this reason, anti-VEGF drugs, in particular ranibizumab, as become the treatment of choice for neovascular AMD. Ranibizumab use is limited by its high cost. Also, ranibizumab requires repeated (sometimes up to monthly) intravitreal injections for many years. Strategies to reduce the burden of this treatment on the patient as well as on the health care system will be critical. Combination therapy is an attractive such possibility. Transpupillary thermotherapy (TTT) is a technique by which vascular occlusion can be induced by delivering radiation at near infrared intensity to the target tissue through the pupil. Several reports have indicated that TTT may be used to slow disease progression in patients with neovascular AMD. In this study we examine whether combined ranibizumab and TTT will reduce the number of ranibizumab injections compared with ranibizumab alone (sham TTT). The study will go on for 2 years with an interim report after 1 year.
Condition or disease Intervention/treatment Phase

Neovascular Age-related Macular Degeneration

Biological: ranibizumab
Other Names
Lucentis
Procedure: TTT
Other Names
Procedure: Sham TTT
Other Names
Phase 3

Tracking Information

First Submitted DateJanuary 10, 2008
Last Update Posted DateNovember 21, 2011
Start DateFebruary 01, 2008
Actual Completion DateFebruary 01, 2010
Primary Completion DateNovember 01, 2009
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab [Time Frame: 1 year]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart [Time Frame: 1 year]

  • Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart [Time Frame: 1 year]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleThe Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study
Official TitleA Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-related Macular Degeneration (AMD)
Brief Summary

Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss in the Western world. Intravitreal ranibizumab has recently become the treatment of choice for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. The investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.

Detailed Description

Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. For this reason, anti-VEGF drugs, in particular ranibizumab, as become the treatment of choice for neovascular AMD. Ranibizumab use is limited by its high cost. Also, ranibizumab requires repeated (sometimes up to monthly) intravitreal injections for many years. Strategies to reduce the burden of this treatment on the patient as well as on the health care system will be critical. Combination therapy is an attractive such possibility. Transpupillary thermotherapy (TTT) is a technique by which vascular occlusion can be induced by delivering radiation at near infrared intensity to the target tissue through the pupil. Several reports have indicated that TTT may be used to slow disease progression in patients with neovascular AMD. In this study we examine whether combined ranibizumab and TTT will reduce the number of ranibizumab injections compared with ranibizumab alone (sham TTT). The study will go on for 2 years with an interim report after 1 year.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
100
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Neovascular Age-related Macular Degeneration
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Biological: ranibizumab

0.5 mg intravitreal injection

Other Names
Lucentis
Procedure: TTT

Transpupillary thermotherapy (TTT)

Other Names
Procedure: Sham TTT

Sham Transpupillary thermotherapy (TTT)

Other Names
Study Groups/Cohorts
TTT
TTT is given every three months

Sham TTT
Sham TTT is given every three months

Study Arms
Sham Comparator Sham TTT
Sham TTT is given every three months
Biological : ranibizumab
0.5 mg intravitreal injection

Sham Comparator Sham TTT
Sham TTT is given every three months
Procedure : Sham TTT
Sham Transpupillary thermotherapy (TTT)

Active Comparator TTT
TTT is given every three months
Biological : ranibizumab
0.5 mg intravitreal injection

Active Comparator TTT
TTT is given every three months
Procedure : TTT
Transpupillary thermotherapy (TTT)

Arm Intervention/Treatment
Sham Comparator Sham TTT
Sham TTT is given every three months
Biological : ranibizumab
Sham Comparator Sham TTT
Sham TTT is given every three months
Procedure : Sham TTT
Active Comparator TTT
TTT is given every three months
Biological : ranibizumab
Active Comparator TTT
TTT is given every three months
Procedure : TTT

Recruitment Information

Recruitment Status:Completed
Enrollment100
Completion DateFebruary 01, 2010
Eligibility Criteria: Inclusion Criteria:
- patients with subfoveal neovascular AMD with either classic/predominantly classic or occult lesions
- visual acuity => 20/200

Exclusion Criteria:
- subretinal fibrosis or atrophy under the fovea
- patients previously treated for neovascular AMD in the study eye
GenderAll
Age50 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Sweden

Administrative Information

NCT Number:NCT00599222
Other Study ID Numbers
LUTA001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyAnders Kvanta, St. Erik Eye Hospital
Study Sponsor
Anders Kvanta
Collaborators
Not Available
Investigators
Principal Investigator
Anders Kvanta
St Eriks Eye Hospital